SEC Comment Letter for HEMOBIOTECH INC (CIK 0001301348) — Feb 17, 2005
HEMOBIOTECH INC (CIK 0001301348)
Date: Feb. 17, 2005 · CIK: 0001301348 · Accession: 0000000000-05-007920
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File numbers found in text: 333-122097
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Mail Stop 0309 February 17, 2005
Arthur Bollon Ph.D.
President and Chief Executive Officer
Hemobiotech, Inc.
14221 Dallas Parkway, Suite 1500
Dallas, Texas 75254
Re: Hemobiotech, Inc.
Registration Statement on Form SB-2, filed January 18, 2005
File No. 333-122097
Dear Dr. Bollon:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
General
1. Please note that where we provide examples to illustrate what
we
mean by our comments, they are examples and not complete lists.
If
our comments are applicable to portions of the filing that we have
not cited as examples, please make the appropriate changes in
accordance with our comments.
2. In your next amendment, please update the financial statements
and
the related discussion and disclosure through December 31, 2004.
As
to all other disclosure, provide updated information as of the
date
you file your amendment.
3. We note that you refer to your product as "novel" throughout
the
prospectus. Where you first use this term, please revise your
disclosure to briefly explain what makes this product novel.
4. Please provide us annotated documentary support for the
following
statements.
* "The United States faced an estimated shortfall of more than one
million units of safe blood in 2003."
* "New York City, for example, is importing more than 25% of its
blood supply from Europe."
* "More than 43% of all blood products are used for people 65 and
older. This older segment is expected to grow 14% in the next 10
years, almost twice as fast as the rest of the population. Thus,
the
shortage of red blood cells is expected to increase dramatically
..."
* The actual cost of a red blood cell transfusion ...currently
ranges
between $500-$1,000 per unit of blood.
Registration Cover Page
5. Please confirm to us that you will file another registration
statement to register any additional shares of common stock
issuable
upon conversion of the 10% convertible unsecured promissory notes
(and in payment of accrued interest in respect of such notes)
above
the 3,441,191 shares you are registering pursuant to this
registration statement.
Prospectus Cover Page
6. Please provide a price or range at which the selling
shareholders
will sell the shares. After providing such price or range if you
intend to have your shares quoted on the OTC Bulletin Board, you
may
also state that "the selling shareholders will sell at a price of
$x.xx (or a range) per share until our shares are quoted on the
OTC
Bulletin Board and thereafter at prevailing market prices or
privately negotiated prices."
7. In addition, in an appropriate place in the prospectus, please
provide the disclosure required by Item 505 of Regulation S-B
regarding determination of offering price. We may have further
comments.
Summary, pages 1-3
8. The forepart of your prospectus contains a lot of jargon or
technical terms. For example, these words and phrases appear in
forepart of your prospectus:
* "hemoglobin"
* "bovine"
* "erythropoesis"
* "pathologic reaction"
* "hemorrhagic shock"
* "molecular studies"
Please replace all technical language and jargon with language
that
can be understood by persons who do not work in your industry.
Alternately, if you cannot find substitute language without
changing
the meaning, prove an explanation of the term where you first use
it.
See Rule 421(d)(2)(ii) of Regulation C.
9. Please define "HemoTech" where it is first used.
10. We note that currently you appear to highlight certain
positive
aspects of your company and its strategy. The summary section
should
provide a brief, but balanced description of the key aspects of
the
company as of the latest practicable date. Please revise your
summary
to balance the discussion with an equally prominent discussion of
the
risks and obstacles in implementing your strategy. This also
means
that you cannot satisfy the comment by merely providing a cross-
reference to the risk factors section. For example, you should
briefly discuss that you have no revenues, have a history of
losses,
expect to continue to incur substantial losses and may not
generate
significant revenue, have only one potential product, and do not
expect to receive regulatory approvals for at least several years,
if
ever. You should quantify your losses for the two most recent
years
and interim period.
Recent Financing Transaction, page 1
11. In your next amendment, please revise to update how much you
are
required to pay in liquidated damages and how much of such amount
you
have already paid.
Risk Factors, pages 4-15
12. Please revise each subheading to ensure it reflects the risk
that
you discuss in the text. Many of your subheadings currently
either
merely state a fact about your business, such as "Our success
depends
in large part on our current key personnel and collaborative
partners
and our ability to attract and retain additional key personnel and
collaborative partners" and "We depend on collaboration with and
licenses from third parties" or describe an event that may occur
in
the future, such as "We have issued convertible unsecured
promissory
notes to fund our operations which become due and payable upon the
earlier to occur of October 27, 2005 or the completion of an
additional financing in which we receive gross proceeds of not
less
than $4.0 million." Succinctly state in your subheadings the
risks
that result from the facts or uncertainties.
"We are a development stage company . . . ." page 4
13. Please revise to disclose your losses for the last 2 fiscal
years
and any relevant interim period.
"We have experienced operating losses since our inception." page 5
14. Please revise your disclosure in this risk factor to briefly
describe your "planned operations." This additional disclosure
will
help investors better understand the impact of a change in your
capital resources or expenditures.
15. Please quantify the amount of additional financing you expect
you
will need to complete your planned operations.
16. Please incorporate into this discussion the rate at which you
are
currently burning cash on a monthly basis.
"We have issued convertible unsecured promissory notes to fund our
operations . . . ." page 5
17. Please disclose here how much you will receive for the
exercise
of the warrants.
18. Please revise your disclosure to briefly describe the material
rights and remedies available to the holders that could be adverse
to
your business.
19. Your statements that you have sufficient funds to meet your
operating expenses and capital requirements and you will be
required
to obtain additional funding in the amount of $10 million to $15
million within the next 10-12 months appear inconsistent.
Additionally, these statements do not appear consistent with the
statement on page 21 that you will need to raise at least $5
million
in the next 10 months, and possibly significantly earlier. Please
advise or revise.
"We have historically had and continue to have negative cash flow
. .
. ." page 6
20. We note your statement that you "have sufficient funds to meet
your operating expenses and capital requirements until October
2005."
Please revise to quantify the amount of funds you have and to
briefly
describe what operating expenses and capital requirements these
funds
will meet. This additional disclosure will help investors better
understand the impact of a change in your capital resources or
expenditures and the impact on your need to raise $10 to $15
million
in the next 10-12 months.
If our human blood substitute product offerings are not
commercially
successful, we will be unable to successfully generate revenue,"
page
7
21. Please revise to explain that acceptance by third party payers
will be necessary in order to be commercially successful.
"Our success depends in large part on our current key personnel
and
collaborative partners . . . ." page 7
22. To the extent that you have experienced problems attracting
and
retaining key personnel in the recent past, please revise to
describe
these problems. Additionally, if any key employee has plans to
retire or leave your company in the near future, please revise the
discussion to disclose this information.
23. Identify scientific advisors and third parties upon which you
depend.
24. Please discuss your dependence on collaborative partners in a
separate risk factor, naming key collaborative partners. In such
risk factor, briefly describe material agreements with such
collaborative partners and the risks associated with such
agreements.
"We depend on collaboration with and licenses from third parties."
page 8
25. It appears that your only current collaboration is that with
Texas Tech. You should move your risk factor "We depend on . . .
from Texas Tech" to precede this one.
26. In addition, please clarify in this risk factor and the
subheading that the risk to you now is your ability to enter into
future collaborations, as you currently have none other than with
Texas Tech.
"We depend on intellectual property licensed from Texas Tech."
Page 8
27. Please revise to describe any provisions which would allow
Texas
Tech to terminate your agreement.
28. Have you already issued all 814,585 shares of common stock to
Texas Tech? If not, please revise to disclose when these shares
are
payable. If they are payable over the life of the agreement or
based
on sales of your product if regulatory approval is received, then
revise to explain. If any shares have been issued, disclose haw
many
have been issued and disclose the value of those shares.
"We have no laboratory, research or development facilities or
manufacturing capabilities, and are dependent on Texas Tech for
some
of these services." page 10
29. It appears that you are currently dependent on Texas Tech for
"all" of these services. If so, please revise this risk factor
and
subheading appropriately. If not, please explain to us.
"The market for human blood substitute products is competitive . .
.
." pages 10-11
30. Please revise to identify the key competitors you expect to
compete with and whether they have products or product candidates
that are further advanced that yours.
"We may be unable to defend or protect our intellectual property .
.
. ." page 11
31. Please update to disclose whether there have been threats of
litigation or negotiations regarding patent issues or other
intellectual property, court challenges, legal actions, etc.
"We do not intend to pay dividends to our stockholders ..." page
13
32. Please revise to clarify that investors might not receive a
return on their investment when they sell their shares in your
company.
"Our common stock may be considered a "penny stock" and be
difficult
to sell when desired." page 14
33. Please revise the risk factor heading to clarify that your
common
stock "will be" considered a penny stock or explain why you
believe
it might not be a penny stock.
34. Please expand to discuss the specific legal remedies available
to
investors of penny stocks.
"A significant number of our shares will be eligible for sale . .
.
." page 14
35. Please also revise to disclose the number of any additional
shares you currently expect to issue and generally when those
shares
will be available for sale. For example, please describe any
shares
you expect to issue pursuant to outstanding options and when the
terms of those options will permit those shares to be salable.
"Our management and principal stockholders own a substantial
amount
of our common stock ..." page 15
36. Please revise to indicate that your management and principal
stockholders are capable of controlling your affairs, as opposed
to
merely influencing them.
"Some provisions of our certificate of incorporation and bylaws
may
deter takeover attempts . . . ." page 15
37. Please revise to disclose here the salary payments you may be
required to make if employment is terminated without just cause or
due to a "Disability."
38. Please revise to also explain that these provisions may lead
to
the entrenchment of management.
"Unfavorable changes in accounting rules or interpretations may
negatively affect our financial performance." page 15
39. Your risk factor as currently written could apply to any
issuer
or offering. Please revise it so that it addresses your situation
more specifically.
Use of Proceeds, page 17
40. Please revise to disclose here the maturity date of the 10%
convertible unsecured promissory notes and the use of proceeds of
the
notes as required by Item 504 of Regulation S-B.
41. Please revise to briefly describe the "certain other
indebtedness" you refer to in this section, including the interest
rate and maturity of such indebtedness.
Management`s Discussion and Analysis or Plan of Operation, pages
20-
22
42. Please refer to the Division of Corporation Finance "Current
Issues and Rulemaking Projects Quarterly Update" under section
VIII -
Industry Specific Issues - Accounting and Disclosure by Companies
Engaged in Research and Development Activities. You can find it
at
the following website address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm.
Please disclose the following information for each of your major
research and development project(s):
* The nature, timing and estimated costs of the efforts necessary
to
complete the project;
* The anticipated completion dates;
* The risks and uncertainties associated with completing
development
on schedule, and the consequences to operations, financial
position
and liquidity if the project is not completed timely; and finally
* The period in which material net cash inflows from significant
projects are expected to commence.
To the extent that information requested above is not known or
estimable, disclose that fact and the reason why it is not known.
43. Please revise to briefly describe the "indebtedness" you refer
to
in this section that you expect repay with the proceeds from the
private placement. Please also briefly describe your current
outstanding indebtedness.
44. We note your statement on page 20 relating to findings of non
US
preclinical trials. In instances where you discuss any trials
conducted to date, please revise to clarify that later stage
trials
might not support these findings.
Business, pages 23-31
General
45. Most of the language in this section is too technical for
average
investors to understand. Please revise the disclosure to
substitute
the technical language for language that is simple and can be
understood by investors. Set forth below are a few examples of
language that should be simplified. You should consider these as
illustrative and not exhaustive of the language that should be
simplified. Please clarify the following statements and phrases:
* "nephrotoxic, neurotoxic, oxidative or inflammatory reactions"
* "vasodilatory activity and can reduce the vasoconstriction that
follows hemorrhage"
* "HemoTech is created by reacting pure bovine hemoglobin with o-
adenosine 5`-triphosphate ("o-ATP"), o-adenosine and reduced
glutathione ("GSH"). These cross-linking agents for intra